(12 days)
Not Found
No
The device description and intended use focus on the physical properties and surgical application of ossicular prostheses, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is a prosthesis used in surgery to bridge defects in the ear, directly treating a medical condition.
No
Explanation: The device is a surgical implant (prosthesis) used to bridge the stapes or incudal process in the middle ear, which is a treatment or replacement function, not a diagnostic one.
No
The device description clearly details physical components made of nitinol, fluoroplastic, and titanium, indicating it is a hardware medical device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description clearly states these are prostheses intended to be implanted in the middle ear during surgical procedures to address issues with the stapes and incus. This is an in vivo application (within the body).
- Lack of IVD Characteristics: There is no mention of examining bodily specimens, diagnostic testing, or providing information for diagnosis based on laboratory analysis.
The devices described are surgical implants used to restore hearing function by replacing or bridging damaged ossicles in the middle ear. This falls under the category of implantable medical devices, not IVDs.
N/A
Intended Use / Indications for Use
For SMart Offset Stapes Piston prosthesis:
Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery when this anatomical condition is present.
For SMart ISJ Prosthesis:
Bridging defects at the long incudal process with otherwise intact mobile chain.
Product codes (comma separated list FDA assigned to the subject device)
ETB
Device Description
For SMart Offset Stapes Piston prosthesis:
The SMart Offset Stapes Piston utilizes nitinol wire embedded in a fluoroplastic shaft. It is offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. The offset ranges from 1mm to 2mm. The device is supplied sterile.
For SMart ISJ Prosthesis:
The SMart ISJ Prosthesis utilizes a nitinol shaft and loops welded to a titanium bell. It is offered in lengths of offset 2.25 mm and 3.25 mm. The device is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Middle Ear (stapes, incudal process)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical revision (in patients with a shortened incudal process) and primary surgery.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
For SMart Offset Stapes Piston prosthesis: The Angular Piston sold by Heinz Kurz GmbH Medizintechnik
For SMart ISJ Prosthesis: The Angular Prosthesis (Plester) sold by Heinz Kurz GmbH Medizintechnik
(No K/DEN numbers for predicates were provided in the document for the subject devices.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.
0
NOV 2 4 2003
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits. The digits are '16033554'. The numbers are written in black ink on a white background. The numbers appear to be written in a casual, slightly slanted style.
Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Summary of Safety and Effectiveness
| Trade Name: | SMart Offset Stapes Piston prosthesis |
|---|---|
| Common Name: | Middle Ear Piston |
| Classification Name: | Partial Ossicular Replacement Prosthesis (9 |
| 874.3450) | |
| Official Contact: | Gregory Sredin |
| Manager of Regulatory Affairs | |
| Gyrus ENT | |
| 2925 Appling Road | |
| Bartlett, TN 38133 | |
| Telephone: | (901) 373-0200 |
| Telefax: | (901) 387-3914 |
| Date Prepared: | October 31, 2003 |
The SMart Offset Stapes Piston is substantially equivalent to the Angular Piston sold by Heinz Kurz GmbH Medizintechnik
Intended Use
The SMart Offset Stapes Piston has the same intended use as the Angular Piston: bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery when this anatomical condition is present.
Material
The SMart Offset Stapes Piston differs from the predicate device in the material used. The predicate device used titanium whereas the SMart Offset Stapes Piston utilizes nitinol wire embedded in a fluoroplastic shaft. This is the same combination of materials that is utilized in the Gyrus ENT SMart Piston that was cleared by the FDA in K003214. (See Exhibit 6)
1
510(k) Summary of Safety and Effectiveness
| Trade Name:
Common Name:
Classification Name: | SMart ISJ prosthesis
Partial Ossicular Replacement Prosthesis
Partial Ossicular Replacement Prosthesis (S 874.3450) |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Gregory Sredin
Manager of Regulatory Affairs
Gyrus ENT
2925 Appling Road
Bartlett, TN 38133 |
| Telephone:
Telefax: | (901) 373-0200
(901) 387-3914 |
| Date Prepared: | October 31, 2003 |
The SMart ISJ Prosthesis is substantially equivalent to the Angular Prosthesis (Plester) sold by Heinz Kurz GmbH Medizintechnik
Intended Use
The SMart ISJ Prosthesis has the same intended use as the Angular Prosthesis: bridging defects at the long incudal process with otherwise intact mobile chain.
Material
The SMart ISJ Prosthesis differs from the predicate device in the material used. The predicate device uses gold and titanium whereas the SMart Offset Piston utilizes nitinol shaft and loops welded to a titanium bell.
2
Table of Similarities and Differences
SMart Offset Stapes Piston vs. Angular Piston
| | SMArt Offset Stapes Piston
(Gyrus ENT) | Angular Piston
(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bridging the stapes in cases of otosclerosis:
specifically for surgical revision in patients
with a shortened incudal process, and also in
primary surgery when this anatomical
condition is present | Bridging the stapes in cases of otosclerosis:
specifically for surgical revision in patients with
a shortened incudal process, and also in
primary surgery when this anatomical condition
is present | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is also biocompatible
and was chosen for its shape-memory
characteristics that allow the surgeon
to close the open loops around the
incus using a heat source in addition to
manual crimping. |
| Shaft material | Fluoroplastic | Titanium | Different. Fluoroplastic has a long
history as an implant material and was
chosen for its ability to be molded
around the shaft of the loops |
| Lengths | 3.0 mm through 6.0 mm (functional length) | 6.0 mm (overall length) | Comparable. The SMart is offered in
lengths of 3 - 6 mm, in 1-mm
increments to assist the surgeon in
selecting the optimal length for his
patient |
| Shaft Diameter | .4, .6, .8 mm | .4, .6 mm | Comparable. In addition to the .4 and
.6 mm shaft the SMart is also offered
in a .8 mm diameter for the surgeon
seeking more stability. Similar shaft
diameters are found in the Gyrus ENT
SMart Piston (K003214) |
| Offset | 1mm to 2mm | 2 mm | Comparable. The SMart piston will be
offered in offset lengths between 1 and
2 mm to allow the surgeon greater
flexibility in selecting the appropriate
size for his patient. |
| | Sterile | Sterile | Same |
3
SMart ISJ prosthesis vs. Angular Prosthesis
| | SMart ISJ Prosthesis
(Gyrus ENT) | Angular Prosthesis
(Heinz Kurz GmbH Medizintechnik) | Similarities or Differences |
|-------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Bridging defects at the long incudal
process with otherwise intact mobile chain. | Bridging defects at the long incudal process
with otherwise intact mobile chain. | Same. No new indications for use. |
| Loop material | Nitinol | Titanium | Different. Nitinol is also
biocompatible and was chosen for its
shape-memory characteristics that
allow the surgeon to close the open
loops around the incus using a heat
source in addition to manual
crimping. |
| Bell material | Titanium | Titanium/Gold | Same |
| Lengths of offset | 2.25 mm, 3.25 mm | 2.25 mm, 3.25 mm | Same |
| How supplied | Sterile | Sterile | Same |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
NOV 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gyrus, ENT L.L.C. c/o Gregory Sredin Manager of Regulatory Affairs 2925 Appling Road Bartlett, TN 38133
Re: K033554
Trade/Device Name: SMart™ Offset Stapes Piston Prosthesis SMart™ ISJ Prosthesis
Regulation Number: 21 CFR 874.3450 Regulation Name: Partial ossicular replacement prosthesis Regulatory Class: Class II Product Code: ETB Dated: November 10, 2003 Received: November 12, 2003
Dear Mr. Sredin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Gregory Sredin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Paizi Kiremthed
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Food and Drug Administration 510(k) Notification – SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Number: Device Name:
SMart Offset Stapes Piston Prosthesis
Indications for Use:
- . Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Counter
(Per 21 CFR 801.109)
Keren Golan
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devise
510(k) Number K033554
OR
Over-the-
(Optional Format 1-2-96)
7
Food and Drug Administration 510(k) Notification - SMart Partial Ossicular Replacement Prosthesis November 10, 2003
510(k) Number: Device Name:
SMart ISJ Prosthesis
Indications for Use:
- Bridging defects at the long incudal process with otherwise intact mobile chain. ●
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| Counter | |
| (Per 21 CFR 801.109) |
OR
Over-the-
(Optional Format 1-2-96)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K033554